FDA clears Bendit’s steerable vascular microcatheter
December 12, 2025
The Bendit17 steerable microcatheter aims to advance navigational control through complex anatomies in vascular procedures.
The Bendit17 steerable microcatheter aims to advance navigational control through complex anatomies in vascular procedures.
The Spring is the only FDA-approved FIT in a range of lengths and diameters, allowing for patient personalisation
PLANO, Texas, Dec. 11, 2025 /PRNewswire/ — Vesalio, a leader in thrombectomy solutions, today announced FDA 510(k) clearance and the upcoming U.S. commercial launch of enVast™, the first and only clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation. enVast introduces a proven, innovative approach to clot capture and removal, redefining coronary thrombectomy for patients with large thrombus burden (LTB).
Neurovalens announced that it received FDA de novo approval for Modius Lean, its non-invasive neurotechnology for weight management.
Flow Neuroscience’s at-home depression treatment device has become the first of its kind to be approved by the FDA.
Lumos Labs’ LumosityRx is positioned for use alongside other ADHD treatment modalities such as medication and therapy.
Ceribell (Nasdaq:CBLL) announced that it received FDA 510(k) clearance for its proprietary delirium monitoring solution.
HeartBeam (Nasdaq:BEAT) announced today that it received FDA 510(k) clearance for its 12-lead electrocardiogram (ECG) synthesis software.
Intuitive (NASDAQ: ISRG)+
announced today that the FDA cleared its da Vinci single port (SP) surgical robot for use in new types of procedures.
HeartBeam’s ECG software duplicates the 12-lead ECG approach undertaken in healthcare settings with electrodes to evaluate heart arrhythmias.